NCT01429493

Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases

Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.

Conditions

• Bone Metastases

Interventions

Type	Name	Description
RADIATION	Conventional Radiotherapy	Conventional radiotherapy will be used (8 Gy/ 1 fraction).
RADIATION	Biological image-guided radiotherapy with conventional dose.	Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used.
RADIATION	Biological image-guided SBRT with dose-escalation.	Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-05-01
• Completion: 2015-12-01
• First posted: 2011-09-07
• Last updated: 2022-12-16

Locations

2 sites across 1 country: Belgium